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Contact Us

For questions regarding ordering the redesigned Lioresal® intrathecal (baclofen injection) kit, please contact Amneal Pharmaceuticals Customer Service at 833-289-8559 or amnealorders@cardinalhealth.com.

For questions regarding the SynchroMed® II Pump, please contact Medtronic at 888-638-7626.

Please refer to the full Lioresal® Intrathecal (baclofen injection) prescribing information and the SynchroMed® infusion system information for details about these products.

 

Amneal US Corporate Office

400 Crossing Boulevard, 3rd Floor

Bridgewater, New Jersey 08807

Phone: (908) 947-3120

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.